跳至主要内容
临床试验/NCT00139880
NCT00139880已完成3 期

A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease

UCB Pharma1 个研究点 分布在 1 个国家开始时间: 2005年6月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
UCB Pharma
试验地点
1

研究概览

简要总结

To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.

详细描述

See approved Package Insert for Adverse Event information.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable Parkinson's disease

排除标准

  • idiopathic PD with Hoehn and Yahr state II or III

研究者

发起方
UCB Pharma
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验